Under New Ruling, Many Antibacterial Soaps No Longer Approved By The FDA

BALTIMORE (WJZ) — Makers of anti-bacterial soaps containing certain ingredients have been ordered by the U.S. Food and Drug Administration to no longer market their products.

“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

The FDA issued a proposed rule in 2013 after some data suggested that long-term exposure to certain active ingredients used in antibacterial products, like triclosan in liquid soaps and triclocarban in bar soaps, could pose health risks, such as bacterial resistance or hormonal effects.

Under the proposed rule, manufacturers were required to provide the agency with additional data on the safety and effectiveness of the anti-bacterial ingredients used in their products if they wanted to continue making them.

This included data from clinical studies demonstrating that these products were superior to non-antibacterial washes in preventing human illness or reducing infection.

Antibacterial hand and body wash manufacturers did not provide the necessary data to establish safety and effectiveness for the 19 active ingredients addressed in this final rulemaking, and manufacturers have already started phasing them out.

After the new ruling, they will have one year to comply by removing products from the market or reformulating them.

In response to comments submitted by industry, the FDA has deferred rulemaking for one year on three additional ingredients used in consumer wash products – benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX) – to allow for the development and submission of new safety and effectiveness data for these ingredients.

The new rule does not affect consumer hand sanitizers or wipes, or antibacterial products used in health care settings.

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